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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01760031
Other study ID # RenPro1L
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 28, 2012
Last updated December 28, 2012
Start date July 2012
Est. completion date January 2013

Study information

Verified date December 2012
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.


Description:

Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 81
Est. completion date January 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility All patients who participated to the RenPro trial

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Other:
Ischemic preconditioning
Subjects received ischemic preconditioning previous to cardiac catheterization

Locations

Country Name City State
Germany University of Cologne Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulat — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MACCE Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint):
All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis
1 Year Yes
Secondary Renal function changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups. 1 year Yes
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